Inspections, Compliance, Enforcement, and Criminal Investigations
Ming's Food, Inc. 11/16/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
November 16, 2011
Mr. Ming Cheng, Owner
Ming's Food, Inc.
5697 New Peachtree Road
Chamblee, GA 30341
Dear Mr. Cheng:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food warehouse and processing facility, located at 5697 New Peachtree Road, Chamblee, Georgia, from May 23, 2011 through June 3, 2011. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods at Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products manufactured in your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
The inspection also found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section whenever a HACCP plan is necessary, or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated under section 402(a)(4) of the Act. Accordingly, your fish and fishery products, including large mouth bass, catfish, white eel, tilapia, frog, periwinkle, crab, and lobster, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
During the inspection of your facility, product labels for your bulk Cabbage Mix were collected. We have reviewed your product labels and find that your products are not labeled in accordance with Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). These violations cause your products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
You may find the Act, the CGMP regulation for foods, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance (HACCP Guidance), and the Food Labeling regulations through links on FDA's homepage at http://www.fda.gov.
Your significant CGMP violations include the following:
1. Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). FDA investigators collected three samples for rodent filth analysis and documented significant evidence of rodent activity and insanitary conditions throughout your facility. Specifically, our investigators observed the following evidence of rodents:
• Rodent excreta pellets (REPs) too numerous to count were observed on a brown 110 lb bag of peanuts located on the western wall in the dry goods area;
• One REP was observed underneath the sink in the processing room restroom;
• At least 169 REPs, at least 19 rodent urine stains, rodent gnawed material, a live apparent beetle, and rodent hairs were observed during a bag-by-bag examination of a pallet of (b)(4) Potato Starch in the dry goods area;
• Seventeen REPs were observed on the floor underneath a comingled pallet on a product rack adjacent to freezer F1;
• Over 25 REPs and at least 9 rodent urine stains were observed during a bag-by-bag examination of a pallet of 44 lb bags of (b)(4) Potato Starch. Our investigators also observed rodent gnawed material throughout the pallet, REPs and a rodent urine stain inside the product, one dead fly, apparent bird excreta, and rodent hair.
• Six rodent gnaw holes ranging from 1/4" - 1" in diameter and 3 rodent urine stains were observed during a bag-by-bag examination of a comingled pallet of (b)(4) brand and (b)(4) brand potato starch stored in the west wall pallet storage area.
We acknowledge that prior to the close of the inspection, you voluntarily disposed of the products our investigators found with evidence of rodent contamination. However, you have an underlying rodent problem in your facility, as evidenced by rodent excreta pellets, urine stains, and nesting materials found on site.
2. Your firm failed to hold raw materials in bulk, or in containers designed and constructed so as to protect against contamination and in such a manner as to prevent the food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.80(a)(5). Specifically, our investigators observed cabbage intended to be used in manufacturing cabbage mix stored on a rolling cart and directly touching the cooler floor, which had standing water.
3. Your employees failed to wear outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food packaging materials, as required by 21 CFR 110.10(b)(1). Specifically, your noodle room employees were observed preparing egg roll skins without wearing aprons, hairnets, and other protective gear, such as beard covers if applicable.
4. Your firm failed to provide restroom doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against such contamination, as required by 21 CFR 110.37(d)(4). Specifically, your employee restroom door opens directly into the processing area where cabbage is sliced and bagged.
5. Your firm failed to properly store equipment and remove litter and waste within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). Specifically, our investigators observed approximately 40 prefabricated freezer sections, 4 large cardboard boxes filled with compressed cardboard and other refuse, several wooden pallets, plastic bins, metal scraps, and other debris along the northern outside perimeter wall of your facility.
6. Your firm failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition and in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a). Specifically, our investigators observed 3 out of 5 bay doors with gaps between the bottom of the doors and the floor measuring approximately 3' x 1", 4' x 1", and 3' x 1." Further, the ventilation fan on the west wall did not have a screen and the ventilation shutters remained open.
Your significant seafood HACCP violations include the following:
You must have a HACCP plan that, at a minimum, lists the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits, as required by 21 CFR 123.6(c)(4). However:
1. Your firm's HACCP plan for 'Pasteurized and Smoked Fish and Seafood' lists monitoring procedures at the receiving and cooler storage critical control points that are not adequate to control "Bacterial Pathogens." Specifically:
• At the receiving critical control point, your monitoring procedures state that you will "check temperature or delivery truck" with a digital thermometer for every order received. However, checking the temperature of the delivery truck at receiving will not adequately control "Bacterial Pathogens." A one time temperature check is adequate only when products have been in transit to your facility for less than 4 hours. For products that are delivered within 4 hours, FDA recommends monitoring the internal temperature of a representative number of product containers and documenting the date and time the products were removed from the controlled environment before shipment as well as the date and time of delivery.
For products that have been in transit to your facility for 4 hours or more, FDA recommends obtaining transportation records that show the products were held at or below 40°F throughout transit. This may be accomplished through the data output from a continuous temperature-recording device that monitors and records the ambient air temperature of the delivery truck during transit.
• At the cooler storage critical control point, your monitoring procedures state that you will monitor the temperature of your cooler every (b)(4) hours during business hours and/or check ice levels simultaneously. However, monitoring the temperature of the cooler every (b)(4) hours during business hours will not adequately control "Bacterial Pathogens." FDA recommends that you monitor the cooler temperature on a continuous basis through the use of a continuous temperature-recording device, such as a recording thermometer or a recorder chart. In addition, checking ice levels would be adequate for products held on ice, i.e., to monitor the adequacy of ice surrounding the product, at a frequency that is sufficient to ensure control.
2. Your firm's HACCP plan for "Fresh Mackerel, Tuna, Bluefish, and Mahi Mahi" lists monitoring procedures at the receiving and cold storage critical control points that are not adequate to control scombrotoxin formation. Specifically:
• At the receiving critical control point, your monitoring procedures reference monitoring ice and internal ''truck" temperature, while your critical limits reference monitoring ice and internal "fish" temperature. There should be consistency throughout the temperature monitoring procedures of your firm's HACCP plan.
• At the cold storage critical control point, your monitoring procedures reference monitoring ice and "cooler" temperatures, while your critical limits again reference monitoring ice and internal "fish" temperature. In addition, your monitoring procedures state that you will monitor the temperature of your cooler every (b)(4) hours during plant operating hours. However, monitoring the temperature of the cooler every (b)(4) hours during plant operating hours will not adequately control scombrotoxin formation. FDA recommends that you monitor the cooler temperature on a continuous basis through the use of a continuous temperature-recording device, such as a recording thermometer or a recorder chart.
Because your bulk Cabbage Mix product does not bear a label containing all of the information required by 21 CFR Part 101, this product is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Specifically, your Cabbage Mix product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear a statement of identity on the principal display panel, as required by 21 CFR 101.3(a).
We acknowledge receipt of your FDA 483 response, dated June 15, 2011. However, this response is inadequate in that you did not provide documentation of your corrections. Without further documentation, we are unable to conduct an informed evaluation of the adequacy of the corrections. For example, in your response, you stated that your firm has started maintaining sanitation logs. However, you did not provide us with any photocopies of your complete sanitation logs. Other examples of documentation that may aid in verifying your corrections include photographs, written procedures, and other pertinent records. We acknowledge that your response also identifies proposed corrections to be completed at a future date. FDA will evaluate any corrective actions you have taken during its next inspection of your facility.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or with respect to your products. You are responsible for ensuring that your facility and your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct these violations and to implement procedures to prevent such violations from recurring. Failure to do so may result in regulatory action by FDA without further notice. Such action includes seizure and/or injunction.
In addition to the violations discussed above, we have the following comments:
1. In regard to your Cabbage Mix product label:
• Your Cabbage Mix product label declares the net weight in pounds only. The net quantity of contents must also be separately and accurately stated in a uniform location upon the principal display panel of the label in SI metric units, as required by 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA), and your product does not appear to be exempt from this requirement. Under 15 U.S.C. § 1453(a)(ii), if the separate label statement of net quantity of contents is on a random package, the label is not required to, but may, include a statement in terms of the SI metric system. In addition, under 15 U.S.C. § 1453(a)(6), foods that are packaged at the retail store level are not required to include a statement in terms of the SI metric system.
• Your Cabbage Mix product label contains information in both English and Chinese, but not all the information appears in both languages. In accordance with 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
2. Your firm informed our investigator during the inspection that lobsters that have died in the lobster tank will be frozen (i.e. to be sold as food). We advise you that a product violates section 402(a)(5) of the Act if it is, in whole or in part, the product of an animal which has died otherwise than by slaughter [21 U.S.C. § 342(a)(5)].
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the noted violations. Please refer to the HACCP Guidance for information and guidance on developing, updating and/or implementing your HACCP plans. Please also include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Please send your written response to the Food and Drug Administration, Attention: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have any questions regarding any issue in this letter, please contact Mrs. Morton at (404) 253-1285 or write her at the noted address.
Atlanta District Office